Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01176344
Registration number
NCT01176344
Ethics application status
Date submitted
4/08/2010
Date registered
6/08/2010
Date last updated
9/09/2015
Titles & IDs
Public title
VItamin D Effect on Osteoarthritis Study
Query!
Scientific title
Does Vitamin D Supplementation Prevent Progression of Knee Osteoarthritis? A Randomised Controlled Trial
Query!
Secondary ID [1]
0
0
VIDEO605501
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
VIDEO
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Vitamin D
Treatment: Drugs - Placebo
Experimental: Vitamin D supplementation - Participants in the intervention arm will receive 50,000 IU (1.25 mg) cholecalciferol capsules given once monthly
Placebo Comparator: Placebo - The control arm will receive identical inert placebo capsules given once monthly.
Treatment: Drugs: Vitamin D
50,000 IU (1.25 mg) cholecalciferol capsules once monthly for 2 years
Treatment: Drugs: Placebo
Inert placebo capsules once monthly for 2 years.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Loss of knee cartilage volume
Query!
Assessment method [1]
0
0
Cartilage volume will be assessed using magnetic resonance imaging (MRI)
Query!
Timepoint [1]
0
0
Over 2 years (Cartilage volume will be assessed at baseline and 2 years later)
Query!
Primary outcome [2]
0
0
Change in knee pain
Query!
Assessment method [2]
0
0
Assessed using WOMAC
Query!
Timepoint [2]
0
0
Over 2 years
Query!
Secondary outcome [1]
0
0
Progression of knee cartilage defects
Query!
Assessment method [1]
0
0
Knee cartilage defects will be measured using MRI.
Query!
Timepoint [1]
0
0
Over 2 years (Cartilahe defects will be measured at baseline and 2 years later)
Query!
Secondary outcome [2]
0
0
Change in bone marrow lesions
Query!
Assessment method [2]
0
0
Assessed using MRI
Query!
Timepoint [2]
0
0
Over 2 years
Query!
Secondary outcome [3]
0
0
Change in knee pain
Query!
Assessment method [3]
0
0
Assessed using VAS
Query!
Timepoint [3]
0
0
Over 2 years
Query!
Secondary outcome [4]
0
0
Change in physical function
Query!
Assessment method [4]
0
0
Assessed using WOMAC function
Query!
Timepoint [4]
0
0
Over 2 years
Query!
Secondary outcome [5]
0
0
Change in joint effusion
Query!
Assessment method [5]
0
0
Assessed using MRI
Query!
Timepoint [5]
0
0
Over 2 years
Query!
Secondary outcome [6]
0
0
Central blood pressure
Query!
Assessment method [6]
0
0
Radial applanation tonometry
Query!
Timepoint [6]
0
0
one year
Query!
Secondary outcome [7]
0
0
Aortic stiffness
Query!
Assessment method [7]
0
0
Carotid to femoral pulse wave velocity
Query!
Timepoint [7]
0
0
one year
Query!
Eligibility
Key inclusion criteria
1. Age 50-79 years old;
2. Men and women with symptomatic knee osteoarthritis (OA) with a pain visual analogue
scale (VAS) of at least 20 mm in most days of the last month;
3. Have an American College of Rheumatology (ACR) functional class rating of I, II and
III;
4. Have relatively good health (0-2 according to the investigator's global assessment of
disease status on a 5-point Likert scale, range 0 [very well] to 4 [very poor]);
5. Have serum vitamin D level of >12.5 nmol/L and <60 nmol/L;
6. Are able to read, speak and understand English, capable of understanding the study
requirements and willing to co-operate with the study instructions;
7. Are able and willing to give informed consent;
8. Are willing and able to give blood samples;
9. Are willing and able to have knee MRIs performed
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
79
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Have Grade 3 radiographic changes in their knee which is to be investigated;
2. Have severe knee pain (more than 80 mm on a 100-mm visual analogue scale,VAS) in most
days of the last month;
3. Have any contra-indications for having MRIs scans performed;
4. Have had significant trauma to the knees including arthroscopy or significant injury
to ligaments or menisci of the knee within 1 year preceding the screening visit;
5. Have ever had knee joint replacement;
6. Have anticipated need for knee or hip surgery in the next 2 years;
7. Have any stomach or intestinal condition possibly affecting oral drug absorption;
8. Have any clinically significant condition(s) such as (but not limited to) rheumatoid
arthritis, psoriatic arthritis, lupus, active cancer, cardiac or renal function
impairment or hypersensitivity to vitamin D that in the opinion of the investigator
may compromise their safety or compliance, interfere with evaluation or preclude
completion of the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
413
Query!
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Query!
Recruitment hospital [1]
0
0
Menzies Research Institute, University of Tasmania - Hobart
Query!
Recruitment hospital [2]
0
0
Department of Epidemiology & Preventive Medicine, Monash University - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [2]
0
0
3004 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Menzies Institute for Medical Research
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Monash University
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Observational evidence suggests that vitamin D deficiency may have a role in the causes of
osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There
is, however, no evidence which shows that intervening with vitamin D supplementation can slow
the progression of OA. This study is to determine if vitamin D supplementation can reduce
knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use of MRI
will provide sensitive measures of knee OA changes.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01176344
Query!
Trial related presentations / publications
Ding C, Cicuttini F, Parameswaran V, Burgess J, Quinn S, Jones G. Serum levels of vitamin D, sunlight exposure, and knee cartilage loss in older adults: the Tasmanian older adult cohort study. Arthritis Rheum. 2009 May;60(5):1381-9. doi: 10.1002/art.24486.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Changhai Ding, MD
Query!
Address
0
0
Menzies Research Institute & Monash University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01176344
Download to PDF